Abbott supports patients with advanced heart failure with mechanical pumps that restore blood flow to the body, both for the short- and long-term. We design our pumps to be gentle on the blood while they are working so that patients can live longer and fuller lives.
For a complete listing of potential adverse events please see the CentriMag System, HeartMate II or HeartMate 3 LVAD Adverse Events section listed below.
*PMA approval for 30-day use of CentriMag™ System components include: CentriMag™ Pump, CentriMag™ Console, CentriMag™ Motor, Mag Monitor, flow probe, and CentriMag™ Drainage Cannula and CentriMag™ Return Cannula. Optional accessories include: CentriMag™ System Cart, CentriMag™ System Transporter and Pressure Transducer. PMA approval for 30-day use of CentriMag™ System excludes: PediMag™ Blood Pump and any other pediatric components or accessories.
*Based on HeartMate 3™ LVAD highest published survival and lowest published stroke and thrombosis rates in a randomized controlled trial in the continuous-flow LVAD category of devices in the U.S.1,2-6
***HeartMate 3™ LVAD demonstrated superiority in event-free survival (primary endpoint) in the MOMENTUM 3 trial compared to HeartMate II™ LVAD.
Rx Only
Brief Summary: Prior to using these devices, please review the Instructions For Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
Indications: The HeartMate 3 Left Ventricular Assist System is indicated for providing short- and long-term mechanical circulatory support (e.g., as bridge to transplant or myocardial recovery, or destination therapy) in patients with advanced refractory left ventricular heart failure.
Indication: The HeartMate II Left Ventricular Assist System is indicated for use as a “bridge to transplantation” for cardiac transplant candidates who are at risk of imminent death from non-reversible left ventricular failure. It is also indicated for use in patients with New York Heart Association (NYHA) Class IIIB or IV end-stage left ventricular failure, who have received optimal medical therapy for at least 45 of the last 60 days, and who are not candidates for cardiac transplantation. The HeartMate II™ Left Ventricular Assist System is intended for use both inside and outside of the hospital, or for transportation of Left Ventricular Assist Device patients via ground ambulance, airplane, or helicopter.
Contraindications: The HeartMate 3 and HeartMate II Left Ventricular Assist System is contraindicated for patients who cannot tolerate, or who are allergic to anticoagulation therapy.
Adverse Events:Adverse events that may be associated with the use of the HeartMate 3 or HeartMate II Left Ventricular Assist System include, but are not limited to those listed below: death, bleeding, cardiac arrhythmia, localized infection, right heart failure, respiratory failure, device malfunctions, driveline infection, renal dysfunction, sepsis, stroke, other neurological event (not stroke-related), hepatic dysfunction, psychiatric episode, venous thromboembolism, hypertension, arterial non-central nervous system (CNS) thromboembolism, pericardial fluid collection, pump pocket or pseudo pump pocket infection, myocardial infarction, wound dehiscence, hemolysis (not associated with suspected device thrombosis) and pump thrombosis.
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Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.
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The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) of Abbott Medical Japan GK.
The information provided here is not intended to provide information to patients and the general public.
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